ISO 15189 Accreditation Readiness: A Gap Assessment for Medical Laboratories
ISO 15189 is the international standard medical laboratories are accredited to. It proves both a working quality system and technical competence for each test you report. Only accreditation bodies can grant it. Accredify Global runs an independent gap assessment, following real samples through your lab, so you know where you stand before the assessors arrive. You get a tailored proposal after a free scoping review.
What Is ISO 15189?
ISO 15189 is the international standard for quality and competence in medical laboratories. It covers the whole testing process: the request, patient preparation, sample collection and transport, the examination itself, and the report. A lab that meets it is accredited by a national accreditation body for a defined list of examinations.
The standard goes further than a quality system. Accreditation bodies check that each method is validated or verified and that measurement uncertainty is known. They also check that results compare well in external quality assessment. That is why it is accreditation, not certification.
Accredify Global does not grant this accreditation. We provide an independent readiness gap assessment. We also certify the ISO 9001 and ISO 27001 systems many laboratory groups run alongside it.
ISO 15189:2022: The Current Edition and What Changed
The 2022 edition is the only one you can be accredited to. It was published on 6 December 2022. The three-year transition ended in December 2025, and accreditations to the 2012 edition are no longer valid.
The structure changed. Requirements now sit in clauses 4 to 8, in line with ISO/IEC 17025:2017. The standard opens with impartiality, confidentiality, and requirements about patients. Risk management carries more weight throughout.
Point-of-care testing moved in. Requirements that used to sit in ISO 22870 are now in Annex A. Labs that oversee testing on wards, in clinics, or at the bedside must show how they control it.
Sources: ISO 15189:2022 guidance (UKAS) · ISO 15189:2022 transition (ILAC)
ISO 15189 Accreditation vs ISO Certification
Some providers sell a medical lab "certificate". Laboratories and their clients should know why that is not the same thing.
| Aspect | Lab accreditation | ISO 9001 certification |
|---|---|---|
| Granted by | A national accreditation body | An accredited certification body |
| What it proves | Technical competence for listed examinations, plus a quality system | A quality management system meets ISO 9001 |
| Assessed by | Lead assessors plus technical experts in each discipline | Management system auditors |
| Scope | A schedule of named tests and methods | Activities and sites |
| Recognized | Internationally, through the laboratory accreditation arrangement | Internationally, for the management system |
Which Laboratories Need Medical Lab Accreditation?
Any lab examining human samples whose clients, regulators, or partners want proof of competence.
Clinical chemistry, haematology, microbiology, and blood banks. See ISO certification for healthcare.
Independent labs competing for hospital and insurer contracts.
Anatomic pathology, cytology, and digital pathology services.
Sequencing, PCR, and genomic testing services.
Central labs serving pharmaceutical sponsors in several countries.
Labs overseeing testing on wards, in clinics, or at home.
In the U.S., clinical labs must meet CLIA, administered by CMS. Accreditation to the standard is voluntary there, and accreditation bodies such as A2LA and the CAP offer it. In the EU, in-house IVD devices in health institutions draw on EN ISO 15189 under the IVDR.
ISO 15189 Requirements, Clause by Clause
The 2022 edition sets its requirements in clauses 4 to 8. These are what we test in each.
| Clause | What it covers | What we look for |
|---|---|---|
| 4. General | Impartiality, confidentiality, and requirements about patients | Impartiality risks recorded and patient information protected |
| 5. Structure & governance | Legal entity, lab director, activities, objectives, and risk | A director with defined duties and a clear scope of examinations |
| 6. Resources | Personnel, facilities, equipment, calibration, reagents, and suppliers | Competence records, traceable calibration, and reagent lot checks |
| 7. Processes | Pre-examination, examination, post-examination, nonconforming work, data, complaints, and continuity | Validation, uncertainty, QC, external quality assessment, and critical results |
| 8. Management system | Documents, records, risks, improvement, corrective action, internal audit, and review | Audits and reviews that lead to real changes |
Following a Sample Through the Laboratory
Assessors trace real samples from request to report. Our gap assessment does the same.
How It Compares: ISO/IEC 17025, ISO 9001, CLIA, and ISO 13485
Laboratories often meet several of these at once. Here is what each one covers.
| Standard or rule | Focus | How it relates |
|---|---|---|
| ISO/IEC 17025 | Testing and calibration labs | Same structure; for non-medical testing |
| ISO 9001 | Quality management, any sector | Covers the system, not technical competence |
| CLIA | U.S. federal rules for clinical labs | Mandatory in the U.S.; the lab standard is voluntary |
| ISO 13485 | Medical device quality management | For IVD makers; labs use their devices |
| ISO 27001 | Information security | Protects lab systems and patient results |
How to Get ISO 15189 Accreditation, Step by Step
Six stages from first look to accreditation. We help with the first; your team and your accreditation body handle the rest.
Have an assessment date booked? A free scoping review tells you how much there is to do before then.
Book a free scoping reviewWhat You Receive From the Gap Assessment
Every requirement rated as met, partly met, or missing.
What we found following real samples from request to report.
Validation, verification, uncertainty, and external quality assessment.
How well you control point-of-care testing under Annex A.
Gaps in order of assessment risk, so you fix the right things first.
A short report for the lab director and management.
ISO 15189 Gap Assessment Cost and Timeline
There is no list price. A free scoping review gives you a tailored proposal for the gap assessment.
What drives the cost
- Disciplines: chemistry, haematology, microbiology, and more
- Examinations: how many tests are in your scope
- Sites: main lab, satellite labs, and collection centres
- POCT: devices and locations you oversee
- Starting point: an ISO 9001 system already in place helps
What sets the timeline
| Assessment | Planned around your shifts |
|---|---|
| Closing gaps | Depends on the gap list |
| Evidence | Months of QC and EQA data |
| Accreditation | Set by your accreditation body |
Frequently Asked Questions About ISO 15189
Straight answers on accreditation, the 2022 edition, CLIA, POCT, cost, and timeline.
What is ISO 15189?
ISO 15189 is the international standard for quality and competence in medical laboratories. It covers the whole testing process, from the request and sample collection to examination and the final report. The current edition is ISO 15189:2022.
Is ISO 15189 a certification or an accreditation?
An accreditation. Medical laboratories are accredited to it by a national accreditation body, which assesses technical competence for specific tests. Certification bodies issue ISO certificates for management systems, not ISO 15189 accreditation.
Does Accredify Global issue ISO 15189 certificates?
No. The standard leads to accreditation, which only accreditation bodies grant. Accredify Global provides an independent readiness gap assessment before your accreditation body's assessment.
What is the latest version of ISO 15189?
The 2022 edition, published on 6 December 2022. Accreditations to the 2012 edition stopped being valid at the end of the transition in December 2025.
What changed in ISO 15189:2022?
The requirements were restructured and now open with impartiality, confidentiality, and patient requirements. Risk management gets more weight, and point-of-care testing requirements, formerly in ISO 22870, moved into the standard.
Is ISO 15189 mandatory in the United States?
No. Clinical laboratories in the U.S. must meet CLIA, which CMS administers. Accreditation to the standard is voluntary, though some clients, research sponsors and international partners ask for it.
Who accredits medical laboratories in the U.S.?
Accreditation bodies that are signatories to the international laboratory accreditation arrangement. Examples include A2LA and the College of American Pathologists through its CAP 15189 program.
What is the difference between ISO 15189 and ISO/IEC 17025?
The first is for medical laboratories that examine human samples for patient care. ISO/IEC 17025 is for testing and calibration laboratories in general. Some labs need both for different services.
What is the difference between ISO 15189 and ISO 9001?
ISO 9001 certifies a quality management system in any organization. The lab standard adds technical competence, such as method validation, measurement uncertainty, and external quality assessment. A lab can hold ISO 9001 and still fall short of accreditation.
Does the 2022 edition cover point-of-care testing?
Yes. Since the 2022 edition, Annex A covers point-of-care testing. Labs that oversee testing on wards or in clinics must show how they control it.
What is measurement uncertainty in a medical lab?
It is an estimate of the doubt around a measured result. The standard requires labs to evaluate measurement uncertainty for quantitative examinations and make it available to users when relevant.
How long does ISO 15189 accreditation take?
It depends on your readiness and your accreditation body's schedule. Labs with a working quality system often need several months from application to decision. A gap assessment first helps avoid delays.
How much does an ISO 15189 gap assessment cost?
There is no list price. Cost depends on the number of sites, disciplines and examinations in scope. A free scoping review gives you a tailored proposal.
What happens in a laboratory gap assessment?
We review your quality system against every clause and follow samples through the lab. We then check validation, uncertainty and external quality assessment records. You get a risk-ranked list of gaps to close before your accreditation assessment.
Does Accredify Global write our quality manual or SOPs?
No. We stay independent, so we assess but do not write your system. Your team, or a consultant you choose, closes the gaps we find.
Know Your Gaps Before the Assessors Do
Tell us about your disciplines, sites, and assessment date. We'll scope a gap assessment and send a tailored proposal.
Book your free scoping review →Last reviewed by the Accredify Global certification team.